The invention relates to devices and techniques for monitoring the concentrations of an oxidative gas or vapor.
Medical and surgical instruments have traditionally been sterilized using heat (e.g., exposure to steam), or chemical vapors (e.g., formaldehyde or ethylene oxide). However, both heat and chemical sterilizations have drawbacks. For example, many medical devices, such as fiberoptic devices, endoscopes, power tools, etc. are sensitive to heat, moisture, or both. Additionally, formaldehyde and ethylene oxide are both toxic gases which pose potential health risks to health workers. After sterilization with ethylene oxide, the sterilized articles require long aeration times to remove any remaining toxic material. This aeration step makes the sterilization cycle times undesirably long.
Sterilization using hydrogen peroxide vapor has been shown to have some advantages over other chemical sterilization processes (e.g., see U.S. Pat. Nos. 4,169,123 and 4,169,124). The combination of hydrogen peroxide vapor and a plasma provides additional advantages, as disclosed in U.S. Pat. No. 4,643,876. U.S. Pat. No. 4,756,882 discloses the use of hydrogen peroxide vapor, generated from an aqueous solution of hydrogen peroxide, as a precursor of the reactive species generated by a plasma. The combination of plasma and hydrogen peroxide vapor in close proximity with the sterilized articles acts to sterilize the articles.
Furthermore, use of low concentrations of hydrogen peroxide vapor has other advantages when used for chemical sterilization. Hydrogen peroxide is easy to handle, can be stored for long periods of time, is efficacious, and mixes readily with water. In addition, the products of decomposition of hydrogen peroxide are water and oxygen, which are both non-toxic.
However, there are problems with using hydrogen peroxide for sterilization. First, in order to be effective, devices must be exposed to a specified concentration of hydrogen peroxide. If the concentration of hydrogen peroxide is not sufficient, the article may require longer time and/or higher temperature to achieve sterilization. Second, if too much hydrogen peroxide is present, there is a risk of damaging the sterilized articles, particularly if they contain nylon, neoprene, or acrylic. For hydrogen peroxide absorbent materials, too much peroxide may leave an unacceptable residue on the sterilized article that may be incompatible with the user or patient. In addition, the use of too much hydrogen peroxide increases the cost of sterilization. Third, hydrogen peroxide concentration levels can decrease during the course of the sterilization process due to various factors, such as reactions with some surfaces which are undergoing sterilization, or permeation into and through some plastic materials. Fourth, hydrogen peroxide vapor can condense onto the walls of the sterilization chamber or onto equipment in the chamber, potentially degrading or harming the equipment. It is therefore important to be able to determine the concentration of hydrogen peroxide vapor in the sterilization chamber so that enough hydrogen peroxide is present to be effective, yet not so much that the sterilized articles or other equipment are damaged.
Furthermore, the concentration of hydrogen peroxide vapor can vary from one section of the sterilized articles to another. Even under equilibrium conditions, there may be regions of the sterilization chamber which are exposed to higher or lower concentrations of hydrogen peroxide due to restrictions of diffusion caused by other equipment in the chamber, or by the sterilized articles themselves. In particular, an enclosed volume with only a narrow opening will have a lower concentration of hydrogen peroxide than one with a wider opening. Under dynamic conditions (e.g., hydrogen peroxide is introduced into the chamber via an inlet port while at the same time, it is pumped out of an outlet port), the hydrogen peroxide concentration at a particular position in the chamber is a function of various factors, including the inlet flow, outlet pumping speed, and geometrical configuration of the system""s inlet and outlet ports, sterilization chamber, and other equipment in the chamber, including the sterilized articles.
Various methods for determining hydrogen peroxide concentration levels in sterilization chambers have previously been disclosed. Ando et al. (U.S. Pat. No. 5,608,156) disclose using a semiconductor gas sensor as a means for measuring vapor phase hydrogen peroxide concentrations. The reaction time of the sensor is several tens of seconds, and the relation between the sensor output and the concentration of the hydrogen peroxide vapor varies with changes in pressure. Most hydrogen peroxide vapor sterilization procedures involve several treatment steps, usually including at least one step in vacuum. The response of the sensor to hydrogen peroxide through the treatment steps will therefore change, depending on the pressure used in each treatment step.
Cummings (U.S. Pat. No. 4,843,867) discloses a system for determining the concentration of hydrogen peroxide vapor in situ by simultaneous measurements of two separate properties, such as dew point and relative humidity. A microprocessor is then used to fit the two measurements into a model to calculate the hydrogen peroxide concentration. The method uses an indirect approximation based on a number of empirical assumptions, and the accuracy will vary depending on how closely the conditions in the sterilization chamber resemble those used to develop the model. This method also does not yield information concerning the differing concentrations of hydrogen peroxide at various positions within the sterilization chamber.
Van Den Berg et al. (U.S. Pat. No. 5,600,142) disclose a method of using near-infrared (NIR) spectroscopy to detect hydrogen peroxide vapor. Hydrogen peroxide has an absorption peak at about 1420 nm (nanometers) which can be used to determine its concentration. However, water is always present when hydrogen peroxide is present, since water is a decomposition product of hydrogen peroxide. Because water also absorbs near-infrared radiation at 1420 nm, it interferes with the determination of the hydrogen peroxide concentration. In order to correct for this interference, the water vapor concentration is determined separately by an absorption measurement at wavelengths which hydrogen peroxide does not absorb. This measured water vapor concentration is then used to correct the absorbance at 1420 nm for the contribution due to water. However, this correction measurement also suffers from contributions due to contaminants, such as various organic molecules, which absorb in the spectral region of the correction measurement. Since one does not normally know what organic molecules are present, the correction factor is therefore somewhat unreliable.
Furthermore, the NIR method requires absorption measurements at two different wavelengths and making corrections for the presence of water vapor, organic contaminants, or both. The electronic equipment for doing these corrections is complex and expensive, and the correction for the presence of organic compounds is subject to error. Additionally, the calculated hydrogen peroxide concentration is an average concentration over the volume which absorbs the near-infrared radiation, not a localized measurement of concentration at particular positions within the sterilization chamber.
U.S. Pat. No. 4,783,317 discloses an apparatus for monitoring the concentration of hydrogen peroxide in liquid media, e.g. aqueous solutions for scrubbing the flue gases emanating from waste-incineration plants or large capacity firing systems. By exploiting the exothermic reaction of hydrogen peroxide with reducing agents (e.g. gaseous sulfur dioxide), the apparatus is able to measure the concentration of hydrogen peroxide in the liquid medium. The U-shaped apparatus comprises a thermally insulated measuring cell, a supply line which supplies a partial stream of the liquid from the source to the measuring cell, and a discharge line which returns the liquid to the source. In the measuring cell, the liquid is combined with a small stream of a reducing agent from a separate supply line, and the temperature of the mixture is monitored by a sensor. By comparing this temperature to the temperature of the liquid prior to entering the measuring cell, the apparatus measures temperature rise due to the ongoing exothermic reaction which is a function of the concentration of hydrogen peroxide in the liquid.
In one aspect, the present invention provides an apparatus for monitoring the concentration of an oxidative gas or vapor comprising: a chemical which reacts with the oxidative gas or vapor to produce a heat change, and a temperature probe which measures the heat change. The chemical is coupled to the temperature probe, such as through a carrier. Preferred carriers include vacuum grease, tape, epoxy, or silicone. The carrier can also comprises a gas-permeable pouch or gas-impermeable enclosure with at least one hole.
In another aspect, the apparatus described above can form part of a sterilization system with a control system to produce a desired level of oxidative gas or vapor. The sterilization system ordinarily comprises: a chamber, a door, and a source of oxidative gas or vapor.
In still another aspect, the present invention provides a method of monitoring the concentration of an oxidative gas or vapor comprising: providing a chemical which undergoes a reaction with the oxidative gas or vapor to be monitored so as to produce a heat change, providing a temperature probe which detects the heat produced by the reaction between the chemical and the oxidative gas or vapor to be monitored and which produces an output signal which is a function of the concentration of the oxidative gas or vapor. The chemical coupled to the temperature probe is exposed to the oxidative gas or vapor, and the output signal from the temperature probe is measured so as to determine the concentration of the oxidative gas or vapor.